Position Summary
Responsibilities:
- This role will require routine interaction with business areas across the West Point site.
- The candidate will primarily perform computer system periodic reviews for laboratory systems and manufacturing equipment periodic reviews.
- There is also the potential to support the implementation of a new computerized maintenance system through the review and evaluation of maintenance master data.
- Manage the periodic review schedule and generate reports.
- Identification and review of system procedures; ensuring these procedures are being utilized to perform system backups and security reviews
- Review of software development lifecycle (“SDLC”) documentation to ensure compliance with the Client's procedures.
- Review of events/logs/issues identified for the system during the review period to ensure system performance.
- Confirmation and review of calibration/maintenance actions for the system
- Perform a review/evaluation of completed change records
- Perform an analysis of all information/data collected and generate a report to summarize any findings and conclusions.
Qualifications:
Education (Min): Bachelor's Degree in Engineering or Science plus a minimum of 2 years’ experience in the Pharma industry.
Required Experience and Skills:
- Knowledge of computer validation processes.
- Familiarity with working in a cGxP environment.
- Effective organizational skills.
- Effective communication.
- Strong computer skills.
- Able to work independently.
Preferred Experience and Skills:
- Kneat - Paperless electronic validation system.
- The candidate should be able to work independently and lead or facilitate tasks successfully.